In short
Clinical trials are studying HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST FOLR1 CONJUGATED TO 1-[(2R,3R,4R,5S,52S)-1,2,3,4,5-PENTAHYDROXY-52-{[(2S)-1-{[(2S)-5-CARBAMOYLAMINO-1-OXO-1-{3-[({[(1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12HBENZO[DE]PYRANO[3',4':6,7]INDOLIZINO[1,2-B]QUINOLIN-1-YL]CARBAMOYL}OXY)METHYL]ANILINO}PENTAN-2-YL]AMINO}-3-METHYL-1-OXOBUTAN-2-YL]CARBAMOYL}-7-[(2S,3R,4R,5R)-2,3,4,5,6-PENTAHYDROXYHEXYL]-46,54-DIOXO10,13,16,19,22,25,28,31,34,37,40,43-DODECAOXA-7,47,53-TRIAZANONAPENTACONTAN-59-YL]-2,5-DIOXOPYRROLIDIN-3-YL, also called Rina-S, in several cancers. The trials look at how well it works and, in some studies, how safe it is compared with other treatments.
Key points
- Clinical trials are studying HUMAN IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST FOLR1 CONJUGATED TO 1-[(2R,3R,4R,5S,52S)-1,2,3,4,5-PENTAHYDROXY-52-{[(2S)-1-{[(2S)-5-CARBAMOYLAMINO-1-OXO-1-{3-[({[(1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12HBENZO[DE]PYRANO[3',4':6,7]INDOLIZINO[1,2-B]QUINOLIN-1-YL]CARBAMOYL}OXY)METHYL]ANILINO}PENTAN-2-YL]AMINO}-3-METHYL-1-OXOBUTAN-2-YL]CARBAMOYL}-7-[(2S,3R,4R,5R)-2,3,4,5,6-PENTAHYDROXYHEXYL]-46,54-DIOXO10,13,16,19,22,25,28,31,34,37,40,43-DODECAOXA-7,47,53-TRIAZANONAPENTACONTAN-59-YL]-2,5-DIOXOPYRROLIDIN-3-YL in ovarian cancer, endometrial cancer, and non-small cell lung cancer. The ovarian and endometrial studies are Phase 3 trials, while the lung cancer study is Phase 2. The target groups include people with platinum-resistant ovarian cancer, advanced or recurrent endometrial cancer, and locally advanced or metastatic non-small cell lung cancer. The main endpoints are progression-free survival, overall survival, and objective response rate. All three studies are authorised and are comparing Rina-S with other treatment approaches or studying it as monotherapy.
Overview of the trials
The trial data describe three interventional studies, which means the researchers assign a treatment and then watch what happens. All three studies are authorised and are testing the same named substance, also called Rina-S in the trial titles and summaries.
The studies focus on different cancer types and use different trial phases, including Phase 2 and Phase 3. The main purpose is to see how well the treatment works, and in one study to compare treatment safety and efficacy with other options listed by the investigator.
Platinum-resistant ovarian cancer study
NCT06619236 is a Phase 3 study in platinum-resistant ovarian cancer, which means ovarian cancer that does not respond well to platinum chemotherapy. The study plans to include 532 participants.
This trial compares Rina-S with investigator’s choice of therapy, meaning the study doctor chooses one of the listed standard treatment options for the comparison group. The options listed in the data are pegfilgrastim, paclitaxel, doxorubicin, gemcitabine, and topotecan.
The main endpoint is progression-free survival (PFS), which is the time from randomization until the cancer gets worse or the person dies, whichever happens first. The trial measures this using RECIST v1.1, a standard way to judge changes in solid tumors.
Endometrial cancer study
The study with ID 2024-519818-31-01 is a Phase 3 trial in endometrial cancer, which starts in the lining of the uterus. It includes advanced, recurrent, metastatic, or primary unresectable disease.
This study aims to compare the clinical efficacy of Rina-S with treatment of investigator’s choice in patients whose cancer has come back or gotten worse after prior therapy. The listed comparison drugs are doxorubicin and paclitaxel.
The trial plans to enroll 480 participants. Its primary outcomes are PFS, measured by RECIST v1.1 and reviewed by independent central review, and overall survival (OS), which is the time from study start until death from any cause.
Non-small cell lung cancer study
The study with ID 2025-522107-18-00 is a Phase 2 trial in locally advanced or metastatic non-small cell lung cancer. It plans to enroll 200 participants.
This study is designed to assess the anti-tumor activity of Rina-S as monotherapy, which means it is being studied alone rather than with another cancer drug. The intervention list also includes pegfilgrastim.
The main endpoint is objective response rate (ORR), which is the percentage of patients whose tumors shrink or disappear based on RECIST v1.1 and investigator assessment.
Main study endpoints
Across these trials, the most important outcomes are about tumor control and how long patients live without worsening disease. The data mention PFS, OS, and ORR as the key endpoints.
- PFS asks how long the cancer stays controlled before it grows again.
- OS asks how long patients live after joining the study.
- ORR asks how many tumors shrink or disappear during treatment.
Who the trials are for
These studies are for adults with specific cancers, not for a general cancer population. Each trial focuses on a different group: people with platinum-resistant ovarian cancer, people with advanced or recurrent endometrial cancer, and people with locally advanced or metastatic non-small cell lung cancer.
The endometrial cancer study specifically includes patients with recurrent or progressive disease after prior therapy. The trial data do not give full inclusion or exclusion rules, so only the cancer types and disease settings listed above can be confirmed here.